MEDCUT

GUDID 18052286424246

Soft Tissue Automatic Biopsy System 20G X 200 mm

MEDAX SRL UNIPERSONALE

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID18052286424246
NIH Device Record Key645f40ee-ff4c-4369-91c7-b704577d5523
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDCUT
Version Model NumberMC20200-K0
Company DUNS440211428
Company NameMEDAX SRL UNIPERSONALE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108052286424249 [Primary]
GS108052286424249 [Primary]
GS108052286424249 [Primary]
GS108052286424249 [Primary]
GS118052286424246 [Package]
Contains: 08052286424249
Package: [10 Units]
In Commercial Distribution
GS118052286424246 [Package]
Contains: 08052286424249
Package: [10 Units]
In Commercial Distribution
GS118052286424246 [Package]
Contains: 08052286424249
Package: [10 Units]
In Commercial Distribution
GS118052286424246 [Package]
Contains: 08052286424249
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy
KNWInstrument, Biopsy
KNWInstrument, Biopsy
KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [MEDCUT]

18052283959123Soft tissue automatic biopsy system 20G X 160mm
18052286423621Soft Tissue Automatic Biopsy System 18G X 160 mm
18052286423614Soft Tissue Automatic Biopsy System 18G X 100 mm
18052286424246Soft Tissue Automatic Biopsy System 20G X 200 mm
18052286424239Soft Tissue Automatic Biopsy System 20G X 100 mm

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